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Deciphering the EU clinical trials regulation

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Figure 1: A flow chart for the authorization of clinical trials under the EU Clinical Trial Regulation.

References

  1. Frewer, L.J. et al. Br. Med. J. 340, c1862 (2010).

    Article  CAS  Google Scholar 

  2. European Parliament and the Council. Official J. Eur. Union 27.5.2014, 1–76 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&qid=1454696912906&from=EN (2014).

  3. Hunter, P. EMBO Rep. 12, 110–112 (2011).

    Article  CAS  Google Scholar 

  4. Abou-El-Enein, M., Bauer, G., Reinke, P., Renner, M. & Schneider, C.K. Trends Mol. Med. 20, 632–642 (2014).

    Article  CAS  Google Scholar 

  5. Glickman, S.W. et al. N. Engl. J. Med. 360, 816–823 (2009).

    Article  CAS  Google Scholar 

  6. Mello, M.M. et al. N. Engl. J. Med. 369, 1651–1658 (2013).

    Article  CAS  Google Scholar 

  7. EMA. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/10/WC500174767.pdf (2 October 2014).

  8. Schneider, C.K. et al. Nat. Rev. Drug Discov. 9, 195–201 (2010).

    Article  CAS  Google Scholar 

  9. Meerpohl, J.J. et al. BMJ Open 5, e006666 (2015).

    Article  Google Scholar 

  10. Corrigan-Curay, J. et al. Mol. Ther. 23, 796–806 (2015).

    Article  CAS  Google Scholar 

  11. EMA. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199078.pdf (17 December 2015).

  12. EMA. (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/12/WC500179339.pdf (25 March 2015).

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Acknowledgements

We gratefully thank colleagues from the EMA, the MHRA and the Danish Health Medicines Agency for their valuable comments on earlier drafts of the manuscript.

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Correspondence to Mohamed Abou-El-Enein.

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Abou-El-Enein, M., Schneider, C. Deciphering the EU clinical trials regulation. Nat Biotechnol 34, 231–233 (2016). https://doi.org/10.1038/nbt.3492

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